Poop pills could tame rare liver disease
NCT ID NCT07477782
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether fecal microbiota transplantation (FMT) can improve liver function in people with primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD). 72 participants will receive either FMT or a sham procedure via colonoscopy and later oral capsules. The main goal is to lower certain liver enzymes and bilirubin levels after 48 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fecal microbiota transplantation (FMT)
- What this could lead to
- If successful, FMT could offer a new way to control PSC and reduce the need for liver transplants.
- What could go wrong
- This is an early phase 2 trial with only 72 people. The treatment may not work, and there are risks from the colonoscopy and oral capsules.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males or females * Age ≥18 and ≤75 years * Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC * IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs) * IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment) * ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol/l (with concomitant elevated direct bilirubin). * Treatment with UDCA (13-23 mg/kg/d) for at least 6 months and at the same dosage for at least 3 months * Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly. * Written informed consent signed * Subject affiliated to the French * Social Security System Exclusion Criteria: * Small duct PSC * Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT \> 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG \> 1.5 ULN * Secondary sclerosing cholangitis (notably IgG4-associated cholangitis) * Cirrhosis defined by Liver elastometry \>14.4 kPa or by current or past decompensation of cirrhosis * AST or ALT \> 7 ULN in the last 3 months * Platelets count in the last 3 months \< 100 000/mm3 * Albumin in the last 3 months \<35g/L * Prothrombin index in the last 3 months \< 70% * Hepatic comorbidity: HBV infection (defined by positive Ag HBS), HCV infection (defined by positive HCV RNA), alcohol abuse (defined by alcohol intake \> 30g/day), metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, Hemochromatosis, Wilson disease, α1-antitrypsin deficiency, celiac disease * History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis * HIV infection * Prior liver transplantation * Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date * History of or established or suspected hepatobiliary carcinoma. * Any severe comorbidity that may reduce life expectancy * History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to inclusion) * Dosage changes of treatment for liver disease in the last 3 months or new treatment for liver disease started in the last 3 months * History of colorectal carcinoma or high-grade dypsplasia in previous screening colonoscopy * History of total colectomy * Current active IBD defined by a partial Mayo score \> 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn's Disease Activity Index (CDAI) \> 150 in patients with Crohn's disease * Changes in IBD treatment or initiation of a new treatment for IBD in the last 3 months * Current treatment with biologics (anti-TNF agent, vedolizumab, ustekinumab) or JAK inhibitors (tofacitinnib) or prednisone \> 10 mg/day or budesonide \> 3 mg /day) (or treatment initiated less than one month) * Any contra-indication to swallow capsules * Renal insufficiency (clearance\<60 ml/min) * Unable to consent, subject to legal or administrative decision (protection measure or deprivation of liberty) or involuntary psychiatric care. * Participation in another interventional research without prior consultation with the investigator responsible for the patient's monitoring in the present study (participation in other non-interventional studies is permitted) * Pregnancy or desire for pregnancy or breastfeeding Randomization criteria * No pregnancy (or desire for in the next year) * No other hepatic pathology: HBV (positive HBs Ag), HCV (positive HCV antibody and positive PCR), autoimmune hepatitis * No HIV infection (positive serology HIV1+2 antibodies) * No documented Clostridium difficile infection at inclusion or \< 10 days preceding randomization (in case of infection discovered at inclusion) * No treatment with antibiotics, antifungics or probiotics \< 4 weeks. * Available FMT with EBV and CMV compatibility
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Inflammatory bowel disease (IBD) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hepatology Department, Saint Antoine Hospital
Paris, 75012, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI learns to measure bowel inflammation from ultrasound
- Can pressurized oxygen heal Crohn's fistulas when drugs fail?
- Can a T-Cell signature unlock the secrets of autoimmune liver disease?
- Can a common supplement ease a rare liver disease?
- Do vegan yogurts and meat substitutes really boost your gut?
- Could a simple workout routine tame IBD symptoms?